510(k) Report

FDA applicant

The Cooper Companies

Pleasanton1 decision1989–19891 recall

FDA records 1 decision for The Cooper Companies (Pleasanton) in 1989: 1 original PMA approval. All are in product code LPM (Lenses, Soft Contact, Extended Wear). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided The Cooper Companies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Cooper Companies since 2007.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — The Cooper Companies by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LPMLenses, Soft Contact, Extended Wear1decision

Who builds on its devices?

Later devices cite its devices 6 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • P890023H55 Hydrophilic Contact LensThe Cooper Companies · 19896cite it

What has FDA decided for it lately?

  • P890023H55 Hydrophilic Contact LensThe Cooper Companies · 19891 recall

The one decision as The Cooper Companies →

What has been recalled?

1 recall linked to its devices; the latest:

  • P890023Soft Contact LensOct 28, 2014Class II

Other applicant names beginning “The”

FDA records each applicant name separately; these may or may not be the same firm.

Cooper Lasersonics, Inc. 54Cooper Biomedical, Inc. 19Cooper-Hewitt Electric Co. 8Cooper Medical Devices Corp. 7Cooper Surgical 6Cooper Medical Corp. 5Cooper Laboratories 1Cooper Surgical/Aesthete 1Cooper Diagnostics, Inc. 1